FREE ON DEMAND WEBINAR

Mastering the design history file: what to include, why it matters, and how to avoid mistakes

Design History Files (DHFs) are vital throughout a product’s lifecycle, but especially when it comes to human factors and usability. Disorganized or incomplete documentation, missing files, inconsistent processes, or unclear rationales can derail acquisitions, stall product evolution, and compromise design intent.

In this webinar, we’ll explore how maintaining clear and comprehensive DHFs not only supports regulatory compliance but also protects user safety, reinforces usability, and sustains product quality. You’ll walk away with an understanding of the essential DHF components tied to human factors, how to avoid common pitfalls, and how great documentation can fuel growth and reduce risk.

We'll cover:

• What belongs in a DHF for human factors and why it matters
• How strong DHFs align with FDA and ISO usability requirements
• Common documentation gaps that derail research and validation
• How solid DHFs streamline handoffs, audits, and acquisitions